API Manufacturing: SOP for Stock Inventory Management and Cycle Counting – V 2.0

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API Manufacturing: SOP for Stock Inventory Management and Cycle Counting – V 2.0

Standard Operating Procedure for Stock Inventory Management and Cycle Counting in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/019/2025
Supersedes SOP/API/019/2022
Page No. Page 1 of 10
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To define the procedure for maintaining accurate stock inventory records and performing routine cycle counting of raw materials, intermediates, and packaging materials in the API manufacturing warehouse, ensuring traceability and preventing discrepancies.

2. Scope

This SOP applies to all GMP-regulated stock items stored within the warehouse, including raw materials, excipients, intermediates, and consumables used in API manufacturing.

3. Responsibilities

  • Warehouse Personnel: Maintain daily inventory records, conduct counting, and report variances.
  • Warehouse Executive: Schedule cycle counts and ensure data is reconciled with physical stock.
  • QA Officer: Review discrepancies, approve reconciliations, and verify stock adjustments.
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4. Accountability

The Warehouse Manager is accountable for accuracy of inventory records and compliance with the documented procedures for stock management and cycle counting.

5. Procedure

5.1 Inventory Management System

  1. Use a validated Inventory Management Software or ERP for stock control.
  2. Each item in the warehouse must have a unique material code and status label.
  3. All inward and outward movements must be recorded in real time.
  4. Maintain the following inventory reports:
    • Material Receipt Register
    • Material Issue Register
    • Stock Balance Sheet

5.2 Labeling and Bin Cards

  1. Each storage bin/pallet must have a bin card indicating:
    • Material name
    • Material code
    • Batch number
    • Quantity
    • Status (Approved/Quarantine/Rejected)
  2. Ensure proper label integrity and barcode functionality where applicable.

5.3 Cycle Counting Procedure

  1. Classify materials as:
    • Class A: High value/critical – monthly
    • Class B: Medium value – quarterly
    • Class C: Low value – annually
  2. Prepare a “Cycle Count Schedule” at the start of each calendar year (Annexure-1).
  3. Perform counting physically and compare with ERP data.
  4. Record results in the “Cycle Counting Log” (Annexure-2).
  5. Report any discrepancies using the “Inventory Discrepancy Form” (Annexure-3).
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5.4 Reconciliation and Investigation

  1. Warehouse Executive and QA shall jointly investigate discrepancies and record root causes.
  2. Correct inventory entries only after approval from QA and closure of investigation.
  3. For significant variances, initiate a deviation report and CAPA.

5.5 Stock Adjustment and Documentation

  1. Stock adjustments must be approved by QA and documented with justification.
  2. Retain all records of counts, reconciliations, and approvals for audit readiness.
  3. Perform trend analysis every quarter to identify recurring issues.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • ERP: Enterprise Resource Planning
  • QA: Quality Assurance
  • CAPA: Corrective and Preventive Action

7. Documents

  1. Cycle Count Schedule (Annexure-1)
  2. Cycle Counting Log (Annexure-2)
  3. Inventory Discrepancy Form (Annexure-3)

8. References

  • ICH Q7 – GMP for Active Pharmaceutical Ingredients
  • WHO TRS 961 – Annex 9: Guidelines on Storage and Distribution
  • 21 CFR Part 211.180(e) – Inventory Control
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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cycle Count Schedule

Material Class Material Name Material Code Scheduled Date Remarks
Class A API-A API001 15/04/2025 Monthly

Annexure-2: Cycle Counting Log

Date Material Batch ERP Qty Physical Qty Variance Counted By
13/04/2025 API-B AP202504 100 kg 98 kg -2 kg

Annexure-3: Inventory Discrepancy Form

Date Material Discrepancy Investigation Summary Corrective Action Verified By
13/04/2025 API-B Short by 2 kg Damaged bag during transfer Revised SOP for bag handling

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2022 1.0 Initial Issue New SOP QA Head
13/04/2025 2.0 Integrated cycle count classification and annexures System Enhancement QA Head
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